Printed from Voxsanity (voxsanity.com.au) — NCT06475443 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06475443
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged 18 or older.
- People whose general health and ability to carry out daily activities meets a certain standard (known as ECOG performance status of 2 or below — confirm with trial site if unsure what this means for a specific situation).
- People who have been diagnosed with HER2-positive breast cancer (a specific type of breast cancer identified by lab testing) that has spread to other parts of the body (metastatic disease).
- People whose brain metastases (cancer that has spread to the brain) have not responded to treatment with specific drugs called fam-trastuzumab deruxtecan-nxki or A1811, and who have not previously had radiotherapy to the brain; people who have had brain surgery and developed new brain lesions after the operation may also be eligible, as long as radiotherapy was not given after the surgery.
- People who have at least one measurable brain lesion confirmed by a contrast-enhanced MRI scan, assessed using a standard measurement system called RANO criteria; measurable disease outside the brain is not required.
- People whose prior treatment history meets specific conditions regarding two drugs called capecitabine and pyrotinib — for example, those who did not experience disease progression or intolerance on these drugs when used earlier (as pre- or post-surgery treatment), and whose disease did not return for at least 6 months after stopping them; use of bisphosphonates, mannitol, and low-dose steroids (less than 2 mg dexamethasone or equivalent) at the same time is permitted (confirm full details of prior treatment requirements with the trial site).
- People with an expected survival of at least 3 months.
- People whose organs are functioning adequately, based on blood tests and heart tests meeting specific thresholds — including healthy enough blood cell counts, liver and kidney function within acceptable ranges, heart pumping function of 50% or above, and a normal heart rhythm measurement on an ECG (confirm specific values with the trial site).
- People who fully understand the study, sign a consent form agreeing to take part, and are willing to follow the study requirements and attend follow-up appointments.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose active brain metastases were previously treated with any anti-tumour therapy other than fam-trastuzumab deruxtecan-nxki or A1811.
- People whose active brain metastases currently require radiotherapy, or people who have cancer spread to the lining of the brain and spinal cord (leptomeningeal metastasis), confirmed by imaging or spinal fluid testing.
- People who need urgent brain surgery (such as removal of a tumour or placement of a drainage shunt), or whose brain metastases are not responding to treatment and are causing serious complications such as uncontrolled pressure in the skull, severe vomiting, mental health changes, seizures, or memory and thinking problems.
- People who have a build-up of fluid in body cavities (such as large amounts of fluid around the lungs or in the abdomen) that cannot be controlled by drainage or other methods.
- People who have received anti-tumour radiotherapy or surgery within 2 weeks before joining the trial; people who have received hormone-based cancer therapy within 1 week before joining; or people who have received chemotherapy, targeted therapy, or immunotherapy within 2 weeks or within 5 half-lives of the first study dose (whichever is shorter); minor procedures such as biopsies or drains are generally permitted.
- People who have participated in another clinical trial of a new drug within the 4 weeks before joining.
- People who are currently being treated with, or have previously been treated with, a type of drug called a HER2 tyrosine kinase inhibitor (examples include lapatinib, neratinib, and pyrotinib).
- People who have had another type of cancer in the past 3 years, with the exception of certain treated cancers such as cervical carcinoma in situ, basal cell skin cancer, squamous cell skin cancer, or papillary thyroid cancer that have been cured.
- People who have serious or uncontrolled health conditions that could affect participation, including: difficulty swallowing, ongoing diarrhoea, or bowel obstruction that could affect how the study drug is taken or absorbed; known allergies to the study drug, a history of immune system disorders (including HIV), or a history of organ transplantation; a history of serious heart conditions such as heart attack or heart failure, or any other heart condition the doctor considers unsuitable; or active serious infection.
- People who are pregnant or breastfeeding; people of childbearing potential who test positive on a pregnancy test at the start of the trial; or people of childbearing potential who are unwilling to use effective contraception throughout the trial.
- People who, for any other reason, are considered by the treating doctor to be unsuitable for this trial.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: +86 15713857388
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Henan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
15 June 2024
Est. completion
30 June 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Objective Response Rate of Intracranial Lesion (CNS-ORR) by investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.